Cigarette SmokingPhase 1NCT06027840
Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use
A Phase 1 study testing Varenicline, Counseling and Guided Self-Change Booklets in people with Cigarette Smoking and E-Cigarette Use, run by Yale University at 1 site in United States.
Trial summary
The purpose of this research study is to understand whether concurrent treatment for cigarettes and e-cigarettes in which an individual quits both products at the same time (QUIT-C) or sequential treatment in which an individual quits cigarettes first followed by e-cigarettes is more effective for quitting both… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking, E-Cigarette Use, Smoking Cessation
- What is being tested?
- Varenicline, Counseling and Guided Self-Change Booklets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 30 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English literate
- Report cigarette smoking, and e-cigarette use for at least the past 3 months
- Smoke 5 or more cigarettes per day
- Report e-cigarette use for at least 14 days in the past month
- Interested in quitting both products in the next month and willing to set a quit date.
Who cannot join
- Vulnerable Populations: Investigators will not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals
- Investigators also will not enroll participants incapable of providing their own consent. The rationale will be provided to the individual as well as his or her family members. Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted.
- Investigators will exclude anyone currently using any smoking cessation services and/or FDA pharmacotherapies.
- Verification of Non-Pregnancy: Females ages <55 will be given a commercially available pregnancy test to verify non-pregnancy. A female of child-bearing age that is currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms with spermicide) for the duration of the study will not be enrolled.
- Individuals using other tobacco or nicotine products besides cigarettes and e-cigarettes > once per week in the last 30 days will be excluded.
- Investigators will exclude individuals with medical contraindications for varenicline use (i.e., severe renal impairment and unstable cardiac history)
- Medical Conditions: Investigators will not enroll anyone with a current, serious uncontrolled medical/psychiatric condition (e.g., a condition that required a hospitalization or intensive outpatient treatment in the past year) based on review by Study Physician that would increase risk of severe adverse events and/or interfere with study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary Test of Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use on Behavior, Tobacco Toxicant Exposure, and Health Effects
The purpose of this research study is to understand whether concurrent treatment for cigarettes and e-cigarettes in which an individual quits both products at the same time (QUIT-C) or sequential treatment in which an individual quits cigarettes first followed by e-cigarettes is more effective for quitting both products. The study will also compare the effect of treatment on health-related biomarkers. All participants will receive varenicline, a medication used to treat tobacco use dependence, counseling, and cessation resources (i.e., links to text-based support, self-change booklet). Varenicline helps to reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products.
Read the detailed description
Inclusion/exclusion criteria will be determined via initial online screening and then confirmed with tele-video/phone call final screening. Non-pregnancy verification will be ascertained via remote pregnancy test.
All participants will be asked to provide assessments (as described below) throughout the sampling process to assess cigarette smoking and e-cigarette use behavior, varenicline use, and use of cessation resources.
This is a 12 week, open-label study of varenicline.
- Conditions
- Cigarette Smoking, E-Cigarette Use, Smoking Cessation
- Being tested
- Varenicline, Counseling, Guided Self-Change Booklets
- Medical subject headings
- Cigarette Smoking, Vaping, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Varenicline prescription will follow the standard induction period: varenicline 0.5 mg once per day for Days 1-3, varenicline 0.5 mg twice per day for Days 4-7, then varenicline 1 mg twice per day (when varenicline reaches peak efficacy for tobacco cessation). Participants will remain on varenicline for 12 weeks total. Dose adjustments (e.g., reduction to 0.5 mg twice per day if 1 mg is not well tolerated) will be allowed at the discretion of the clinical pharmacist/APRN/physician.
CounselingBehavioural
Tobacco Treatment Service clinicians will deliver weekly counseling sessions, monitor participants for adverse events, and record participants' weekly cigarette and e-cigarette use. At the first counseling session clinicians will review medication proper use instructions, and potential side effects and strategies to address them at the first counseling session. Study medication refills will be distributed at 4-week intervals. Sessions will focus on quit plan preparation, supportive and practical cessation counseling, resetting quit dates, and relapse prevention.
Guided Self-Change BookletsBehavioural
The booklet includes information on how to reduce and quit both cigarettes and e-cigarettes on their own, how to prevent relapse, how to set a quit date, and how to enroll in text-based support resources.
| Study group | Role | What they receive |
|---|---|---|
| QUIT-C (Concurrent) | Experimental | Treatment in this arm will emphasize concurrent cessation of cigarettes and e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize concurrent cessation. Receives: Drug: Varenicline; Behavioral: Counseling; Behavioral: Guided Self-Change Booklets |
| QUIT-S (Sequential) | Experimental | Treatment in this arm will focus on cessation of cigarettes followed sequentially by cessation of e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize sequential cessation. Receives: Drug: Varenicline; Behavioral: Counseling; Behavioral: Guided Self-Change Booklets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette Abstinence at Week 12- Carbon Monoxide
7-day point prevalence cigarette abstinence at Week 12, biochemically verified by breath carbon monoxide
Measured: Week 12
Secondary outcomes (4)
E-Cigarette Abstinence at Week 12- Cotinine
7-day point prevalence e-cigarette abstinence at Week 12, biochemically verified by urine cotinine
Measured: Week 12
Number of cigarettes smoked per day
Number of cigarettes smoked per day assessed by self-report
Measured: Baseline up to week 12
Percent days of e-cigarette usage
Percent days of e-cigarette usage assessed by self-report
Measured: Baseline up to week 12
Biomarkers of tobacco-related harm exposure
Primary urinary biomarkers of tobacco-related harm exposure will be assessed including NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), a tobacco carcinogen linked to lung cancer risk.
Measured: Baseline up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Apr 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa Fucito, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027840
- Sponsor's protocol ID
- 2000035713
- Other IDs
- 2P50CA196530-06
- Status last verified
- Jun 2026
- First submitted
- 30 Aug 2023
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Test of Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use on Behavior, Tobacco Toxicant Exposure, and Health Effects
- ClinicalTrials.gov ID
- NCT06027840
- Acronym / sponsor ID
- 2000035713
- Conditions
- Cigarette Smoking, E-Cigarette Use, Smoking Cessation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to understand whether concurrent treatment for cigarettes and e-cigarettes in which an individual quits both products at the same time (QUIT-C) or sequential treatment in which an individual quits cigarettes first followed by e-cigarettes is more effective for quitting both products. The study will also compare the effect of treatment on health-related biomarkers. All participants will receive varenicline, a medication used to treat tobacco use dependence, counseling, and cessation resources (i.e., links to text-based support, self-change booklet). Varenicline helps to reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products.
Detailed description
Inclusion/exclusion criteria will be determined via initial online screening and then confirmed with tele-video/phone call final screening. Non-pregnancy verification will be ascertained via remote pregnancy test.
All participants will be asked to provide assessments (as described below) throughout the sampling process to assess cigarette smoking and e-cigarette use behavior, varenicline use, and use of cessation resources.
This is a 12 week, open-label study of varenicline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QUIT-C (Concurrent) | Experimental | Drug: Varenicline, Behavioral: Counseling, Behavioral: Guided Self-Change BookletsTreatment in this arm will emphasize concurrent cessation of cigarettes and e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize concurrent cessation. |
| QUIT-S (Sequential) | Experimental | Drug: Varenicline, Behavioral: Counseling, Behavioral: Guided Self-Change BookletsTreatment in this arm will focus on cessation of cigarettes followed sequentially by cessation of e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize sequential cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English literate
- Report cigarette smoking, and e-cigarette use for at least the past 3 months
- Smoke 5 or more cigarettes per day
- Report e-cigarette use for at least 14 days in the past month
- Interested in quitting both products in the next month and willing to set a quit date.
Key exclusion criteria (7 listed)
- Vulnerable Populations: Investigators will not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals
- Investigators also will not enroll participants incapable of providing their own consent. The rationale will be provided to the individual as well as his or her family members. Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted.
- Investigators will exclude anyone currently using any smoking cessation services and/or FDA pharmacotherapies.
- Verification of Non-Pregnancy: Females ages <55 will be given a commercially available pregnancy test to verify non-pregnancy. A female of child-bearing age that is currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms with spermicide) for the duration of the study will not be enrolled.
- Individuals using other tobacco or nicotine products besides cigarettes and e-cigarettes > once per week in the last 30 days will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineVarenicline prescription will follow the standard induction period: varenicline 0.5 mg once per day for Days 1-3, varenicline 0.5 mg twice per day for Days 4-7, then varenicline 1 mg twice per day (when varenicline reaches peak efficacy for tobacco cessation). Participants will remain on varenicline for 12 weeks total. Dose adjustments (e.g., reduction to 0.5 mg twice per day if 1 mg is not well tolerated) will be allowed at the discretion of the clinical pharmacist/APRN/physician. | Drug | QUIT-C (Concurrent), QUIT-S (Sequential) |
| CounselingTobacco Treatment Service clinicians will deliver weekly counseling sessions, monitor participants for adverse events, and record participants' weekly cigarette and e-cigarette use. At the first counseling session clinicians will review medication proper use instructions, and potential side effects and strategies to address them at the first counseling session. Study medication refills will be distributed at 4-week intervals. Sessions will focus on quit plan preparation, supportive and practical cessation counseling, resetting quit dates, and relapse prevention. | Behavioural | QUIT-C (Concurrent), QUIT-S (Sequential) |
| Guided Self-Change BookletsThe booklet includes information on how to reduce and quit both cigarettes and e-cigarettes on their own, how to prevent relapse, how to set a quit date, and how to enroll in text-based support resources. | Behavioural | QUIT-C (Concurrent), QUIT-S (Sequential) |
Primary outcome
Cigarette Abstinence at Week 12- Carbon Monoxide
Time frame: Week 12
7-day point prevalence cigarette abstinence at Week 12, biochemically verified by breath carbon monoxide
4 secondary outcomes
E-Cigarette Abstinence at Week 12- Cotinine
Time frame: Week 12
Number of cigarettes smoked per day
Time frame: Baseline up to week 12
Percent days of e-cigarette usage
Time frame: Baseline up to week 12
Biomarkers of tobacco-related harm exposure
Time frame: Baseline up to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Fucito, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Varenicline, Counseling and Guided Self-Change Booklets in people with Cigarette Smoking and E-Cigarette Use, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarette Abstinence at Week 12- Carbon Monoxide (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.